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Completed

NCT Number: NCT07678190

High-Fidelity Simulation in Vaccination Training

This study compared the impact of high-fidelity simulation (HFS) versus standart laboratory practice (SLP) on nursing students' knowledge, psychomotor skills, learning satisfaction, and self-confidence within a childhood vaccination training.

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Key information

Conditions

Simulation-Based Education Behavior Education Nursing Health Behavior Treatment Adherence and Compliance Treatment Refusal Vaccination Hesitancy Vaccination Refusal Vaccination Training

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Zonguldak Bulent Ecevit University

Kozlu, Zonguldak Province, 67600, Turkey (Türkiye)

About this study

This randomized controlled trial evaluated the effectiveness of high-fidelity simulation (HFS) versus standard laboratory practice (SLP) on nursing students' knowledge, psychomotor skills, satisfaction, and self-confidence in childhood vaccination training. A total of 122 fourth-year nursing students were randomly assigned to HFS or SLP groups; 104 completed the study.

All participants received the same theoretical training on childhood immunization. The HFS group participated in a simulation scenario involving vaccine hesitancy, while the SLP group performed traditional laboratory-based practice on a manikin.

Knowledge was assessed using a pre-test, post-test at 1 hour, and a one-month follow-up test. Skills were evaluated immediately after the intervention. Satisfaction and self-confidence were also measured post-intervention.

The primary outcomes were knowledge and skill performance, while secondary outcomes included satisfaction and self-confidence. The study was conducted in accordance with ethical standards, and informed consent was obtained from all participants.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fourth-year nursing students
  • Voluntary participation

Exclusion criteria

  • Did not complete post-tests
  • Non-volunteering

Treatment and study plan

High-Fidelity Simulation

Behavioral

High-fidelity simulation-based training including a vaccine hesitancy scenario, structured briefing, simulation, and debriefing.

Standard Laboratory Practice

Behavioral

Traditional laboratory-based vaccination training using a manikin without a structured simulation scenario.

Primary outcomes

  1. Childhood Immunization Knowledge Test (CIKT)

    Time frame: Baseline, 1 hour after training, and 1 month after training

    A 10-item multiple-choice test developed by the researchers based on national guidelines and literature. Each correct answer is scored as 10 points. Total scores range from 0 to 100, with higher scores indicating greater knowledge of childhood immunization. Expert validation was obtained, and the KR-20 reliability coefficient was 0.93.

  2. Pediatric Intramuscular Vaccination Administration Checklist (PIVAC)

    Time frame: 1 hour after training

    Items are scored from 0 (not performed) to 2 (performed). Total scores range from 0 to 40, with higher scores indicating better pediatric intramuscular vaccination administration skills. The checklist demonstrated expert validity and a Cronbach's alpha of 0.90.

Secondary outcomes

  1. Student Satisfaction and Self-Confidence in Learning Scale (SCLS)

    Time frame: 1 hour after training

    A validated 12-item, 5-point Likert scale with two subscales (Satisfaction and Self-Confidence). Total scores range from 12 to 60, with higher scores indicating greater satisfaction and self-confidence in learning. In this study, Cronbach's alpha was 0.96 for the satisfaction subscale, 0.94 for the self-confidence subscale, and 0.96 for the total scale.

  2. Simulation Design Scale (SDS)

    Time frame: 1 hour after training

    The Simulation Design Scale consists of 20 items rated on a 5-point Likert scale. Total scores range from 20 to 100, with higher scores indicating a more positive evaluation of the simulation design. Cronbach's alpha was 0.98.

Sponsors and collaborators

Lead sponsor

Zonguldak Bulent Ecevit University

Other

Registry information

Official study title

The Effect of High-fidelity Simulation on Childhood Vaccination Training in Nursing Students: A Randomized Controlled Trial

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Jul 1, 2026
Registry last updated
Jul 1, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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